BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME KIT

    MDR report key: 3063419 · Received April 12, 2013

    Report

    Report Number
    1526350-2013-00184
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(4) 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER AIR DERMATOME. CUSTOMERS WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. CUSTOMERS WERE REQUESTED TO CONTACT ZIMMER TO SCHEDULE MAINTENANCE FOR THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 02/23/1989 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. THE INSPECTION OBSERVED THE HEAD AND CONTROL BAR OF THE DEVICE WERE DAMAGED AND THE THICKNESS CONTROL LEVER WAS MISSING. PRIOR TO REPAIR, THE CALIBRATION COULD NOT BE CHECKED DUE TO THE MISSING THICKNESS CONTROL LEVER. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTIVE MAINTENANCE AND HANDLING ACCORDING TO THE INSTRUCTIONS FOR USE. THE ZIMMER AIR DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS AND THE HOSE EVERY 6 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS BEING SET-UP FOR USE AND THE DEPTH GAUGE LEVER WAS MISSING. THERE WAS NO HARM REPORTED. THE REPORTED EVENT OCCURRED DURING PROCEDURE SET-UP, WITH ENOUGH TIME AVAILABLE FOR STAFF TO OBTAIN AN ALTERNATE DEVICE WITHOUT DELAY OF THE SCHEDULED PROCEDURE START.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158097 AIR DERMATOME KIT AIR DERMATOME KIT GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1